Tuesday, Apogee (NASDAQ:APOG) Therapeutics Inc (NASDAQ: APGE) received a reiterated Buy rating with a steady price target of $81.00 from BTIG. The firm's optimism is tied to the initiation of Apogee's Phase 1 trial for APG990, with expectations set for interim safety and pharmacokinetic (PK) data to be available in 2025.
APG990, which targets the same molecule as Sanofi (NASDAQ:SNY)'s amlitelimab, has shown promise in a Phase 2 study for atopic dermatitis (AD), known as STREAM-AD. Apogee's management anticipates that pending results from the ongoing Phase 1 trial could lead to the advancement of APG990 in combination with another of its drugs, APG777, for the treatment of AD and potentially other inflammatory and immune diseases.
The Phase 1 single ascending dose (SAD) trial of APG990 aims to enroll 40 healthy volunteers across five cohorts, with each cohort comprising eight participants. These individuals are expected to be randomized in a 6:2 ratio to receive either the active therapy or a placebo. Positive outcomes from the trial could propel the company to submit an Investigational New Drug (IND) application and move forward with an additional Phase 1 trial combining APG990 with APG777 in 2025.
Meanwhile, Sanofi is projected to release Phase 2b data for amlitelimab in asthma in the second half of 2024. The results from this study are anticipated to potentially influence the outlook for APG990, especially if novel activity is confirmed.
In other recent news, Apogee Therapeutics has made significant strides in its clinical trials and is now focusing on developing novel treatments for asthma and atopic dermatitis (AD). The biotech firm has initiated a Phase 1 clinical trial for APG990, a monoclonal antibody developed for AD, with interim data expected in 2025. Additionally, Apogee is advancing its Phase 2 trial for APG777, another novel antibody targeting AD and asthma, with trial data also expected in 2025.
Apogee Therapeutics has also announced the appointment of Dr. Lisa Bollinger to its board of directors. Dr. Bollinger brings a wealth of regulatory expertise to Apogee's clinical development programs, which is expected to be a valuable asset in guiding the company through clinical trials and potential future approvals.
Financially, Apogee maintains a robust position, with $790 million in assets expected to support the continued development of its pipeline into 2028. Stifel, a financial services company, has maintained its Buy rating on Apogee's stock, reflecting confidence in the company's drug pipeline. These are among the recent developments at Apogee Therapeutics.
InvestingPro Insights
As Apogee Therapeutics Inc (NASDAQ: APGE) progresses with its Phase 1 trial for APG990, a closer look at the company's financial health and market performance provides a broader context for investors. An InvestingPro Tip highlights that APGE holds more cash than debt on its balance sheet, which may offer some financial flexibility as they fund ongoing clinical trials. Additionally, despite the company's strong returns over the last year, with a 106.44% price total return, analysts have revised their earnings downwards for the upcoming period, reflecting caution about near-term profitability.
InvestingPro Data reveals a market cap of $2.93 billion and a negative P/E ratio, reflecting the company's current lack of profitability. The significant price uptick over the last six months, with a 45.04% return, underscores investor optimism which may be tied to the company's developmental milestones. However, with the P/E ratio (adjusted) for the last twelve months as of Q2 2024 standing at -24.7, it's clear that the market is factoring in future growth expectations rather than current earnings.
For investors seeking a deeper dive into Apogee Therapeutics' financials and market performance, there are additional InvestingPro Tips available, providing a comprehensive analysis to support informed investment decisions. These insights can be accessed through the InvestingPro platform.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.